Maine was only the first skirmish. Now the battle to import drugs from Canada has moved to Capitol Hill.
Ned MilenkovichOn January 8, 2015 U.S. Senators John McCain (R-Ariz) and Amy Klobuchar (D-Minn.) reintroduced the Safe and Affordable Drugs from Canada Act of 2015. The bipartisan legislation would allow individuals to import prescription drugs purchased from an approved Canadian pharmacy into the United States. The purpose of this legislation is to mitigate the high cost of prescription drugs in the U.S, which causes many Americans to forgo filling their prescriptions, by allowing individuals to safely import a personal supply from Canada.
The bill was first introduced in July 2014 following a finding that average prescription drug prices in the United States were twice as expensive as those in Canada. Sen. McCain stated, “This legislation would allow individuals to safely import prescription drugs in the United States from our neighbors to the north, spur much-needed competition in the pharmaceutical market, and save individual Americans up to hundreds of dollars a year.” Sen. Klobuchar agreed, saying, “This bill would allow for safe import of these drugs from Canada, let competition in from the border, and bring down costs for American families.”
The legislation also ensures that cost savings associated with importing will not come at the expense of consumer safety. The Safe and Affordable Drugs from Canada Act of 2015 would amend the Federal Food, Drug, and Cosmetic Act (FFDCA) to grant the Department of Health and Human Services (HHS) 180 days to publish regulations allowing Americans to import prescription drugs.
In order to ensure the safety of participating individuals, the regulations would require that HHS approve the Canadian pharmacy, that the dispensing pharmacist be licensed in Canada, and that a licensed U.S. physician issue the prescription being filled.
The drugs imported would also need to be approved prescription drugs under the FFDCA, and quantity restrictions would allow for no more than a 90-day supply. In conjunction with the new regulations, the HHS would also be responsible for creating a certification process for Canadian pharmacies and maintaining an up-to-date list of the pharmacies that have certified.
Maine was first
This legislation would not be the first of its kind. In 2013, Maine enacted similar legislation that allowed residents to purchase drugs from Canada, the United Kingdom, New Zealand, and Australia.
However, Judge Nancy Torresen of the U.S. District Court for the District of Maine recently ruled that Maine’s international importation drug law was unconstitutional due to federal preemption. Judge Torresen stated, “There is a clear Congressional intent to tightly control prescription drug importation.” She went on to say, “The FDC Act occupies the field of importation of pharmaceuticals from foreign countries” not state law.
Judge Torresen’s decision is likely to further motivate Congress and the FDA to reevaluate current drug importation laws.
Representatives of Sens. McCain and Klobuchar stated that “the judge’s ruling adds urgency to their effort.” Senator Klobuchar went on to say that “[t]here is bipartisan support for our bill to allow all Americans to import cheaper prescription drugs from Canada, and this ruling only underscores the importance of passing it into law.”
The Safe and Affordable Drugs from Canada Act of 2015 has been referred to the Senate Committee on Health, Education, Labor, and Pensions.